Providing Qualified Person Batch Certification for chemical and biological products.
Establishing and maintaining quality systems to meet local regulations, including:
- Training teams
- SOP development and maintenance
- Management of quality complaints and deviations
- Corrective and Preventive Action (CAPA) planning and execution
- Coordination and Execution of quality and supplier audits
- Implementation and Management of Quality Agreements/Technical Agreements with suppliers
- Preparing for agency or internal corporate inspections
- Supply chain management
- GMP/GDP Compliance programs
- Preparations of importers for license importation